STEPS: A Virtual Reality-based Intervention for Adults With Autism. (NCT06438536) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
STEPS: A Virtual Reality-based Intervention for Adults With Autism.
Denmark140 participantsStarted 2024-05-02
Plain-language summary
The goal of this clinical trial is to learn if a new Virtual Reality-based intervention will be effective in treating social cognitive challenges in adults with autism.
The main questions it aims to answer are:
1. Is Virtual Reality-based social cognitive training effective in reducing social cognitive deficits and improving psychosocial functioning, quality of life, and clinical symptoms in adults with ASD?
2. Is Virtual Reality-based social cognitive training cost-effective?
Researchers will compare Virtual Reality-based pro-functional, Social Cognitive Training (VRSCT) to treatment as usual (TAU) to evaluate effectiveness.
Participants will be allocated to receive either VRSCT once a week in addition to treatment as usual (TAU) or TAU alone for 3 months. All participants will undergo a thorough assessment at baseline, and at 3 and 6 months post-baseline.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age of 18 years or older
. Ability to give informed consent
. Diagnosis of an autism spectrum disorder (ICD-10 code F84.0; F84.1; F84.5; F84.8)
. T-score on SRS-A self-report ≥ 60
Exclusion criteria
. Rejecting informed consent
. A diagnosis of organic brain disease
. Intellectual disability (IQ ˂ 70)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Social Responsiveness Scale, Adult Version, Self-report
Timeframe: Baseline, 3 month follow-up and 6 month follow-up
Trial details
NCT IDNCT06438536
SponsorUniversity Hospital Bispebjerg and Frederiksberg